David Hoey (Vaxxas)

In for the long vac­cine game, Mer­ck buys in­to patch de­liv­ery tech with pan­dem­ic po­ten­tial

When Mer­ck dived in­to the R&D fray for a Covid-19 vac­cine ear­li­er this week, ex­ecs made it clear that they’re not nec­es­sar­i­ly look­ing to be first — with CEO Ken Fra­zier throw­ing cold wa­ter on the hot­ly-dis­cussed 12- to 18-month time­lines. But when it does emerge from be­hind, the phar­ma gi­ant clear­ly ex­pects to play a sig­nif­i­cant part.

Part of that will de­pend on next-gen­er­a­tion de­liv­ery tech­nol­o­gy that re­shapes the world’s imag­i­na­tion of a vac­cine.

Work­ing with Vaxxas, a long­time part­ner based in Bris­bane, Aus­tralia, Mer­ck has nom­i­nat­ed the first vac­cine can­di­date they want to de­liv­er through the nee­dle-free de­vice. Hav­ing hand­ed over $12 mil­lion in up­front in­vest­ment and fees, Mer­ck is al­so en­ti­tled to two ad­di­tion­al li­cens­es.

While the part­ners stayed tight-lipped about the can­di­date or the dis­ease it seeks to pre­vent, Vaxxas em­pha­sized that the tech­nol­o­gy — with its po­ten­tial for self-ad­min­is­tra­tion, sta­bil­i­ty at high tem­per­a­tures and low­er dosage re­quire­ments — could be “game-chang­ing” in pan­dem­ic sit­u­a­tions.

Speak­ing from his home in Boston, Vaxxas CEO David Hoey told End­points News that the idea is pred­i­cat­ed on the ob­ser­va­tion that the great­est den­si­ty of im­mune cells lie just un­der the sur­face of the skin.

“So if you scratch your skin with a stick when you’re walk­ing, you pret­ty in­stant­ly see a red mark,” he said. “The ini­tial in­flam­ma­tion en­ables the im­mune cells to mi­grate and to see whether or not there is any in­vad­er, if you like, that is present, any for­eign en­ti­ty. And we lever­age that.”

With­in each Vaxxas patch, which bears re­sem­blance to a small tub of oint­ment, are thou­sands of short pro­jec­tions that would send vac­cine anti­gens just there for im­mune cells to take di­rect­ly to the lymph nodes.

The mech­a­nism ren­ders it much more po­tent, he added, than con­ven­tion­al de­liv­ery. In a hu­man tri­al com­par­ing a tra­di­tion­al flu shot to one de­liv­ered by the Vaxxas patch, they found that they were able to in­duce a com­pa­ra­ble im­mune re­sponse with a sixth of the dose.

De­spite the promise, though, skin vac­ci­na­tion has large­ly been con­fined to aca­d­e­m­ic labs be­cause of the dif­fi­cul­ty to man­u­fac­ture at scale.

“You can make 5 or them or 50 of them to do ex­per­i­ments in an­i­mals, but can you make 50 mil­lion of them?” he said.

Cred­it: Vaxxas

Click on the im­age to see the full-sized ver­sion

Vaxxas al­so has aca­d­e­m­ic roots, start­ing out with sci­en­tif­ic ex­plo­ration in­volv­ing Mer­ck’s vac­cines. But since 2011, the com­pa­ny has ramped up its process to the point where it can make 1,000 patch­es per day. The tar­get is to get to 1 mil­lion per week — a scale it hopes to reach in two and a half years through a new al­liance with Har­ro Höfliger.

Mer­ck, which had se­cured ap­proval for its record-set­ting Ebo­la vac­cine just be­fore the Covid-19 out­break in Chi­na took place, bagged two de­vel­op­ment can­di­dates overnight by ac­quir­ing one com­pa­ny and col­lab­o­rat­ing with a non­prof­it. The first, from Aus­tri­an biotech Themis, comes from a measles virus vec­tor-based plat­form; the sec­ond is de­vel­oped by IAVI and ben­e­fits from the same tech­nol­o­gy as the Ebo­la im­mu­niza­tion.

The­o­ret­i­cal­ly, both could be amenable to skin patch de­liv­ery us­ing Vaxxas’ tech, Hoey said: “The patch is vac­cine ag­nos­tic.”

Tesla and SpaceX founder Elon Musk gestures to the audience after being recognized by President Trump following the successful launch of a Falcon 9 rocket at the Kennedy Space Center. (via Getty Images)

Tes­la chief Elon Musk teams up with Covid-19 play­er Cure­Vac to build 'R­NA mi­cro­fac­to­ries'

Elon Musk has joined the global tech crusade now underway to revolutionize vaccine manufacturing — now aimed at delivering billions of doses of a new mRNA vaccine to fight Covid-19. And he’s cutting right to the front.

In a late-night tweet Wednesday, the Tesla chief announced:

Tesla, as a side project, is building RNA microfactories for CureVac & possibly others.

That’s not a lot to go on. But the tweet comes a year after Tesla’s German division in Grohmann and CureVac filed a patent on a “bioreactor for RNA in vitro transcription, a method for RNA in vitro transcription, a module for transcribing DNA into RNA and an automated apparatus for RNA manufacturing.” CureVac, in the meantime, has discussed a variety of plans to build microfactories that can speed up the whole process for a global supply chain.

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Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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George Yancopoulos (Regeneron)

UP­DAT­ED: Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Pos­i­tive Covid-19 vac­cine da­ta? New mouse study? OWS in­clu­sion? Yep, but some­how, the usu­al tid­bits from In­ovio back­fire

You don’t go more than 40 years in biotech without ever getting a product to market unless you can learn the art of writing a promotional press release. And Inovio captures the prize in baiting the hook.

Tuesday morning Inovio, which has been struggling to get its Covid-19 vaccine lined up for mass manufacturing, put out a release that touched on virtually every hot button in pandemic PR.

There was, first and foremost, an interim snapshot of efficacy from their Phase I program for INO-4800.

Jan van de Winkel, Genmab CEO

Seat­tle Ge­net­ics, Gen­mab turn on TV for a high­light reel in cer­vi­cal can­cer — but a ri­val biotech promis­es a bet­ter show

Seattle Genetics $SGEN and their partners at Genmab $GMAB polished up some positive Phase II numbers for their antibody drug conjugate tisotumab vedotin — you can call it TV — for recurrent cervical cancer. And while they mapped out a shortcut to a potential quick approval, the big challenge for this team is being presented by a rival biotech which muscled its way into the spotlight for the same indication a year ago.

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Kiniksa preps BLA as Re­gen­eron drug cruis­es to a PhI­II win — shares soar

Kiniksa made a modest $5 million cash bet on Regeneron’s Arcalyst (rilonacept) back in 2017. The startup forged a pact to use the drug, which targets IL-1α and IL-1β, and see how it works against recurrent pericarditis, agreeing to split any profits to come while putting another $27 million in milestones up for grabs.

And the wager paid off handsomely today, as the biotech’s stock surged on their report of a Phase III success that sets up a near-term FDA application. The drug has already won the FDA’s breakthrough drug designation here, heightening expectations of a regulatory success.